Image-guided biopsy apparatus and methods of use

• US 5,833,627 A
• Filed: 07/12/1996
• Issued: 11/10/1998
• Est. Priority Date: 04/13/1995
• Status: Expired due to Term

• Current Assignee: United States Surgical Corporation (Medtronic Plc)
• Original Assignee: United States Surgical Corporation (Medtronic Plc)
• Inventors: Shmulewitz, Ascher, Ziring, Edo
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US08/680,595
• Time in Patent Office: 851 Days
• Field of Search: 128/653.1, 128/662.03, 128/662.05, 128/749, 128/754, 128/915, 606/130, 606/407, 606/459, 606/461, 606/562, 606/567
• US Class Current: 600/562
• CPC Class Codes: A61B 10/0041 Detection of breast cancer mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2562/168 Fluid filled sensor housings
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/4209 by using holders, e.g. positioning frames
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/17 for soft tissue, e.g. breast-holding devices
• CPC Class Codes: Y10S 128/915 Ultrasound mammography

Abstract

Apparatus and methods are provided for positioning a needle or cannula of a biopsy device for insertion into a tissue mass by correlating, in real-time, the actual needle or cannula position prior to insertion with its probable trajectory once inserted. In a preferred embodiment, a biopsy device support block is mechanically coupled to an ultrasound transducer to provide alignment of the biopsy device with the ultrasound image in at least one plane. Continued ultrasound scanning of a selected trajectory may be provided to assess depth of penetration of the needle or cannula of the biopsy device, when inserted.

Claims

1. Apparatus for positioning a biopsy device having a needle or cannula for insertion into a tissue mass, the apparatus for use in a system including a display, the apparatus comprising:

a first compression plate having first and second surfaces, the tissue mass immobilized against the first surface;

a second compression surface adjacent the first compression plate and defining a compression area therebetween;

an ultrasound transducer disposed adjacent the first compression plate and acoustically coupled to the second surface of the first compression plate;

a biopsy device support block; and

a connecting member for securing the biopsy device support block and the ultrasound transducer, wherein the connecting member maintains alignment of the ultrasound transducer to the biopsy device support block in at least one plane.

2. The apparatus as defined in claim 1 further comprising a biopsy device having a needle or cannula carried in the biopsy device support block, the ultrasound transducer generating an image of the tissue mass including a portion of needle or cannula, the image being displayed on the display.

3. The apparatus as defined in claim 1 wherein the connecting member comprises a C-shaped support arm including first and second legs, the ultrasound transducer is carried on the first leg and the biopsy device support block is carried on the second leg.

4. The apparatus as defined in claim 1 wherein the connecting member maintains alignment of the ultrasound transducer to the biopsy device support block in a second plane orthogonal to the at least one plane.

5. The apparatus as defined in claim 4 wherein the connecting member comprises a transducer support arm, a connector block and an L-shaped support rod, the ultrasound transducer is carried on a transducer support arm and the biopsy device support block is carried on the L-shaped support leg.

6. The apparatus as defined in claim 1, wherein the connecting member further includes a means for determining a vertical displacement of the biopsy device support block relative to the first surface of the first compression plate.

7. The apparatus as defined in claim 6 wherein the means for determining comprises at least one encoder.

8. The apparatus as defined in claim 1 wherein the ultrasound transducer provides real-time imaging of the tissue mass.

9. The apparatus as defined in claim 1 wherein the ultrasound transducer provides imaging of the needle or cannula of the biopsy device after the needle or cannula has been inserted into the tissue mass.

10. The apparatus as defined in claim 1 further comprising a means for moving the second compression surface toward the first compression plate, the means for moving arranged so that the second compression surface is displaced away from a patient'"'"'s chest wall as the second compression surface moves toward the first compression plate.

11. The apparatus as defined in claim 10 wherein the second compression surface is inclined at an angle inward towards the patient'"'"'s chest wall, relative to a plane orthogonal to the patient'"'"'s chest wall.

12. The apparatus as defined in claim 10 wherein the first compression plate is inclined at an angle inward towards the patient'"'"'s chest wall, relative to a plane orthogonal to the patient'"'"'s chest wall.

13. The apparatus as defined in claim 10 wherein a first surface of the second compression surface has a surface that grips the tissue mass to prevent movement of the tissue mass from between the first surface of the first compression plate and the second compression surface when the tissue mass is disposed therebetween.

14. The apparatus as defined in claim 1 wherein the apparatus further comprises a second compression surface and means for moving the second compression surface relative to the first surface to compress the tissue mass therebetween.

15. The apparatus as defined in claim 14 wherein the second compression surface defines an aperture through which the needle or cannula of the biopsy device may be disposed.

16. The apparatus as defined in claim 14 wherein the first surface defines a first area and the second compression surface defines a second area, the second area being substantially smaller than the first area.